Import Alert 98-02

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

In June 2009, the Family Smoking Prevention and Tobacco Control Act (FSPTCA) provided FDA with authority to regulate tobacco products by recognizing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products.

Effective July 22, 2010, tobacco product manufacturers, including importers of regulated tobacco products, may not introduce into domestic commerce any tobacco product for which the label, labeling, or advertising contains the descriptors light, mild, low or similar descriptors, irrespective of the date of manufacture, unless an FDA order is in effect under Section 911(g) of the FD&C Act with respect to such product (Section 911(b)(3) of the FD&C Act). Under Section 902(8) of the FD&C Act, a tobacco product shall be deemed to be adulterated if it is in violation of Section 911 of the FD&C Act.

Guidance:

Districts may detain, without physical examination, the tobacco products identified on the Red List of this import alert.

Districts may detain, without physical examination, smokeless tobacco, cigarettes, cigarette tobacco, or roll-your-own tobacco products that have or are described in the entry declarations as having label, labeling, or advertising containing the descriptors light, low, or mild unless an appropriate FDA order is in effect with respect to such product. Currently, there are no orders in effect for any products. The firms and products with an FDA order in effect will be listed in the Exception list of the import alert.

Under the following circumstances submit labeling, photographs, and entry documents for detention concurrence to the Division of Import Operations (DIO):

1.If Districts encounter imported smokeless tobacco, cigarettes, cigarette tobacco, or roll-your-own tobacco products that are sold or distributed for consumer use and that are declared or labeled with descriptors similar to light, mild, or low, or

2.If Districts encounter imported smokeless tobacco, cigarettes, cigarette tobacco, or roll-your-own tobacco components or parts that are sold or distributed for consumer use and that are declared or labeled with light, mild, low, or similar descriptors.

Requests for reconditioning of regulated tobacco products detained under this Import Alert should be submitted to DIO; DIO will coordinate with CTP for concurrence.

Requests for removal from DWPE should be directed to FDA's Division of Import Operations at:

Food and Drug Administration

Division of Import Operations (HFC-170)

12420 Parklawn Drive, ELEM-3109

Rockville, MD 20857

Or via email: Importalerts2@fda.hhs.gov

Questions related to tobacco products may be directed to the Center for Tobacco Products, Office of Compliance at CTP-ComplianceImports@fda.hhs.gov.

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) (FD&C Act) because it is a tobacco product that appears to be in violation of Section 911. [Adulteration: Section 902(8)FD&C Act]